The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Device Description

The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:

Arc™ Catheter .
Riptide™ Aspiration Tubing .
Riptide™ Aspiration Pump ●
Riptide™ Collection Canister with Intermediate Tubing .

The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.

The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single-use and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Riptide™ Aspiration System to its predicate device, the Penumbra System® and Penumbra Pump MAX™.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists numerous tests conducted on various components of the Riptide™ Aspiration System, with an explicit statement that the device met the acceptance criteria for each. The specific acceptance criteria values are generally not quantified in the "Results" column, but rather stated qualitatively (e.g., "met the acceptance criteria").

Table 1: Acceptance Criteria and Reported Device Performance (Summary)

Component	Test Category	Individual Test	Acceptance Criteria Statement (from document)
Arc™ Catheter	Biocompatibility	USP Physicochemical	Meets USP Physicochemical (Pass)
		ISO MEM Elution Using L-929 Mouse Fibroblast Cells	Non-cytotoxic
		ISO Guinea Pig Maximization Sensitization Test	Non-sensitizer
		ISO Intracutaneous Irritation Test	Non-irritant
		ISO Acute Systemic Injection Test	Non-cytotoxic
		ISO Materials Mediated Rabbit Pyrogen	Non-pyrogenic
		ASTM Hemolysis Assay – Direct Contact and Extract Method	Non-hemolytic
		Complement activation C3a and SC5b-9 Assay	The compliment activation of the C3a and SC5b assays were similar for test and comparison articles.
		Thromboresistance Evaluation	The test and control articles exhibited similar thromboresistant characteristics.
		ISO Bacterial Mutagenicity Test - Ames Assay	Non-mutagenic
		ISO in vitro Mouse Lymphoma with Extended Treatment	Non-mutagenic (non-genotoxic and non-clastogenic)
		ISO in vivo Mouse Micronucleus Assay	Non-mutagenic
		Partial Thromboplastin Time	Non-activator (of intrinsic coagulation pathway)
		in vitro Hemocompatibility Assay	No adverse effect on leukocyte or platelet counts.
Arc™ Catheter	Bench - Microbial	Ethylene Oxide (EO) Residual	Met the acceptance criteria for EO Residual.
		Ethylene Chlorohydrin (ECH)	Met the acceptance criteria for ECH.
		Bacterial Endotoxin	Met the acceptance criteria for Bacterial Endotoxin.
	Bench - Packaging	Visual Inspection	Met the acceptance criteria for Visual Inspection.
		Bubble Leak	Met the acceptance criteria for Bubble Leak.
		Seal Strength	Met the acceptance criteria for Seal Strength.
	Bench - Performance	Lumen Patency	Met the acceptance criteria for Lumen Patency.
		Dimensional Inspection	Met the acceptance criteria for Dimensional Inspection.
		Tip Buckling	Met the acceptance criteria for Tip Buckling.
		Injection Flow Rate	Met the acceptance criteria for Injection Flow Rate.
		Suction Flow Rate	Met the acceptance criteria for Suction Flow Rate.
		Vacuum Resistance	Met the acceptance criteria for Vacuum Resistance.
		Air Aspiration Leak	Met the acceptance criteria for Air Aspiration Leak.
		Hub/Shaft Peak Tensile Force	Met the acceptance criteria for Hub/Shaft Peak Tensile Force.
		Coating Integrity	Characterization only.
		Coating Lubricity/Durability	Met the acceptance criteria for Coating Lubricity/Durability.
		Particulate	Met the acceptance criteria for Particulate.
		Kink Resistance	Met the acceptance criteria for Kink Resistance.
		Liquid Leak	Met the acceptance criteria for Liquid Leak.
		Static/Dynamic Burst	Met the acceptance criteria for Static/Dynamic Burst.
		Corrosion Resistance	Met the acceptance criteria for Corrosion Resistance.
		Torque to Failure	Characterization only.
Riptide™ Aspiration Tubing	Bench - Microbial	Ethylene Oxide (EO) Residual	Met the acceptance criteria for EO Residual.
		Ethylene Chlorohydrin (ECH)	Met the acceptance criteria for ECH.
		Bioburden Recovery	Met the acceptance criteria for Bioburden Recovery.
		Bioburden	Met the acceptance criteria for Bioburden.
		Bacterial Endotoxin	Met the acceptance criteria for Bacterial Endotoxin.
	Bench - Packaging	Aseptic Presentation	Met the acceptance criteria for Aseptic Presentation.
		Seal Width	Met the acceptance criteria for Seal Width.
		Dye Leak	Met the acceptance criteria for Dye Leak.
		Visual Inspection	Met the acceptance criteria for Visual Inspection.
		Bubble Leak	Met the acceptance criteria for Bubble Leak.
		Legibility	Met the acceptance criteria for Legibility.
		Foreign Material	Met the acceptance criteria for Foreign Material.
		Seal Strength	Met the acceptance criteria for Seal Strength.
	Bench - Performance	Dimensional Inspection	Met the acceptance criteria for Dimensional Inspection.
		Identification of Heat Shrink Bands	Met the acceptance criteria for Identification of the Heat Shrink Bands.
		Identification of Flow Switch	Met the acceptance criteria for Identification of the Flow Switch.
		Joint Tensile Strength	Met the acceptance criteria for Joint Tensile Strength.
		Leak (Vacuum and Pressure Decay)	Met the acceptance criteria for Leak.
		Degree of Collapse	Met the acceptance criteria for Degree of Collapse.
		Compatibility (Arc™ Catheter & Collection Canister)	Met the acceptance criteria for Compatibility to the Arc™ Catheter and Riptide™ Collection Canister.
Riptide™ Aspiration Pump	Bench - Performance	Degrees of Tilt	Met the acceptance criteria for Degrees of Tilt.
		Durability	Met the acceptance criteria for Durability.
		Maximum Vacuum	Met the acceptance criteria for Maximum Vacuum.
		Flow Capacity	Met the acceptance criteria for Flow Capacity.
		Electrical Safety	Met the acceptance criteria for Electrical Safety.
		Electromagnetic Compatibility	Met the acceptance criteria for Electromagnetic Compatibility.
Riptide™ Collection Canister with Intermediate Tubing	Bench - Packaging	Packaging Integrity	Met the acceptance criteria for Packaging Integrity.
		Packaging Labeling	Met the acceptance criteria for Packaging Labeling.
	Bench - Performance	Volume Capacity	Met the acceptance criteria for Volume Capacity.
		Volume Marking	Met the acceptance criteria for Volume Marking.
		Canister Strength	Met the acceptance criteria for Canister Strength.
		Overfill Protection	Met the acceptance criteria for Overfill Protection.
		Dimensional Inspection	Met the acceptance criteria for Dimensional Inspection.
		Degree of Collapse	Met the acceptance criteria for Degree of Collapse.
		Port Identification	Met the acceptance criteria for Port Identification.
		Compatibility (Riptide™ Aspiration Pump)	Met the acceptance criteria for Compatibility.
Riptide™ Aspiration System	Bench - System Performance	Simulated Clot Retrieval	Met the acceptance criteria for Simulated Clot Retrieval.
		Vacuum Pressure	Met the acceptance criteria for Vacuum Pressure.
		Flow Rate	Met the acceptance criteria for Flow Rate.
		Lumen Collapse	The Arc™ Catheter is resistant to Lumen Collapse.
		Usability	Met the acceptance criteria for Usability.

Study Information:

The provided document describes non-clinical bench testing and non-clinical animal testing. It explicitly states "Not Applicable" for clinical performance data. Therefore, questions related to human reader studies, ground truth establishment for a test set of clinical images, and training set details are not directly addressed in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- Bench Testing: The document does not specify the exact sample sizes (number of units tested) for each individual bench test. The nature of these tests often involves a batch of devices or components.
- Animal Testing: The document mentions "a porcine model" but does not specify the number of animals used for the animal testing.
Data Provenance:
- Bench Testing: Conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, as part of their R&D and regulatory submission process. Location not specified, but the company is based in Irvine, California, USA.
- Animal Testing: Conducted "in a porcine model." Location not specified.
- Retrospective/Prospective: These are non-clinical studies (bench and animal), so the terms retrospective/prospective in the context of human data acquisition do not directly apply. They are inherently prospective in the sense that the tests were designed and executed to evaluate this specific device for its regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. The studies described are non-clinical (bench and animal). There is no mention of human expert-established ground truth for a test set of clinical images or data. The "ground truth" for these tests comes from objective measurements against defined standards (e.g., ISO, ASTM, USP standards, or internal specifications) and observations in animal models.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As no human expert evaluation of clinical data for ground truth establishment is described, adjudication methods are not relevant to this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states "Performance Data - Clinical: Not Applicable." This means no human reader studies (MRMC or otherwise) were conducted or submitted as part of this 510(k). The device is not an AI-powered system that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is a medical instrument (aspiration system for stroke), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Bench Testing: Ground truth is established by objective measurements against pre-defined engineering specifications, international standards (ISO, ASTM, USP), and validated test methods. For example, "The Arc™ Catheter met the acceptance criteria for EO Residual" means the measured residual levels were below the established safe limits per ISO 10993-7.
Animal Testing: Ground truth is established through direct observation and measurement in a controlled porcine model, in accordance with "21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies". The goal was to evaluate "safety, efficacy, and usability" and compare it to the predicate device.

8. The sample size for the training set

Not Applicable. No AI/machine learning component is described for this device, so there is no concept of a "training set" in the context of algorithm development.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI algorithm mentioned, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

December 21, 2017

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K172448

Trade/Device Name: Riptide™ Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 20, 2017 Received: November 21, 2017

Dear Mr. Ryan Kenney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172448

Device Name Riptide™ Aspiration System

Indications for Use (Describe)

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: K172448

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
	9775 Toledo Way
	Irvine, CA 92618
	Establishment Registration No.: 2029214
Contact Person:	Ryan Kenney
	Senior Regulatory Affairs Specialist
	Telephone: (949) 297-5489
	Email: ryan.j.kenney@medtronic.com
Date Summary Prepared:	December 18, 2017
Trade Name of Device:	Riptide™ Aspiration System
Common Name of Device:	Catheter, Thrombus Retriever
Regulation Description:	Percutaneous Catheter
Review Panel:	Neurology
Product Code:	NRY
Regulation Number:	21 CFR 870.1250
Device Classification:	Class II
Predicate Device(s):	Penumbra System® and Penumbra Pump MAX™
	510(k)#: K160449
Reference Device(s):	Arc™ Intracranial Support Catheter
	510(k)#: K150107
	Penumbra System®/Penumbra System MAX™
	510(k)#: K133317
	Penumbra Pump MAX™
	510(k)#: K122756
	Penumbra Reperfusion Catheter 054
	510(k)#: K090752

Device Description:

Arc™ Catheter .
Riptide™ Aspiration Tubing .
Riptide™ Aspiration Pump ●
Riptide™ Collection Canister with Intermediate Tubing .

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Indications for Use:

	Predicate Penumbra System® andPenumbra Pump MAX™(K160449)	Subject Riptide™ Aspiration System
Indication for Use(IFU) Statement	Reperfusion Catheters andSeparators:As part of the Penumbra System®,the Reperfusion Catheters andSeparators are indicated for use in therevascularization of patients withacute ischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2	The Riptide™ Aspiration System isintended for use in therevascularization of patients with acuteischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. Patients who are ineligible for
	Predicate Penumbra System® andPenumbra Pump MAX™(K160449)	Subject Riptide™ Aspiration System
	segments, basilar, and vertebralarteries) within 8 hours of symptomonset.	intravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PAtherapy are candidates for treatment.
	Penumbra Aspiration Tubing:As part of the Penumbra System®,the Penumbra Sterile AspirationTubing is indicated to connect thePenumbra Reperfusion Catheters tothe Penumbra Pump MAX™.Penumbra Pump MAX™:The Penumbra Pump MAX™ isindicated as a vacuum source forPenumbra Aspiration Systems.
	5MAX™ ACE Reperfusion Catheter	Arc™ Catheter
Materials	Biocompatible, commonly utilizedfor interventional devices.	Same
Coating	Hydrophilic	Same
Markerband	Radiopaque	Same
Guidewire	Yes	Same
Compatible
Dimensions
Usable Length	132cm	132-135cm
Proximal InnerDiameter	0.068"	0.069"
Proximal OuterDiameter	0.083"	0.0825"
Distal InnerDiameter	0.060"	0.061"
Distal OuterDiameter	0.074"	0.071"
Sterilization
Method	Ethylene Oxide (EO)	Same
Packaging
Pouch	Polyethylene	Nylon-Tyvek®
Packaging Hoop	Polyethylene	Same
Packaging Card	Polyethylene	Same
Carton	Solid Bleached Sulfate (SBS)Paperboard	Same
Shelf Life	36 Months	Same
	Penumbra MAX™ Aspiration Tubing	Riptide™ Aspiration Tubing
Materials	Biocompatible, commonly utilized	Same
	Predicate Penumbra System® andPenumbra Pump MAX™(K160449)	Subject Riptide™ Aspiration System
	for interventional devices.
Dimensions
Usable Length	112.0"	Same
Distal Length	7.0"	Same
Inner Diameter	0.088"	Same
Outer Diameter	0.188"	Same
Sterilization
Method	Ethylene Oxide (EO)	Same
Packaging
Shelf Life	36 Months	3 Months
	Penumbra Pump MAX™	Riptide™ Aspiration Pump
Performance Characteristics
Vacuum Range	0-29 inHg (0-98.2 kPa)	Same
Flow Rate	0-0.8 SCFM (0-23 LPM)	Same
Dimensions
Length	15.5"	16.1"
Depth	11.2"	13.2"
Height	13.2"	12.3"
Weight	22.3lbs	23.6lbs
Electrical Requirements
Voltage	100-115 Vac	110-115 Vac
Frequency	50 Hz/60 Hz	60 Hz
Duty Cycle	Non-continuous97.8% (45 minutes on, 1 minute off)	Non-continuous97% (58.2 minutes on, 1.8 minutes off)
IEC 60601-1Compliance	Yes	Same
IEC 60601-1-2Compliance	Yes	Same
	Penumbra MAX™ Canister	Riptide™ Collection Canister withIntermediate Tubing
Dimensions
Volume	1000ml	1200ml

Device Comparison:

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Biocompatibility:

Biocompatibility was performed for the Arc™ Catheter and the Riptide™ Aspiration Tubing. The Arc™ Catheter is categorized as a limited exposure (< 24 hours), external communicating device contacting circulating blood. The Riptide™ Aspiration Tubing is categorized, for worst-case, as a limited exposure (< 24 hours), external communicating device with indirect blood path contact.

ArcTM Catheter
Test Description	Results	Conclusions
USP Physiochemical	Meets USP Physicochemical	Pass.
Arc™ Catheter
Test Description	Results	Conclusions
ISO MEM Elution Using L-929Mouse Fibroblast Cells	extraction parametersThe test article scored '0' at 24, 48 and 72 ± 4 hours and isconsidered non-cytotoxic underthe conditions of this test.	Non-cytotoxic.
ISO Guinea Pig MaximizationSensitization Test	Under the conditions of thisprotocol, the test article did notelicit a sensitization response.	Non-sensitizer.
ISO Intracutaneous IrritationTest	The differences in the mean testand control scores of the extractdermal observations were < 1.0,indicating that the requirementsof the ISO IntracutaneousReactivity Test have been metby the test article.	Non-irritant.
ISO Acute Systemic InjectionTest	None of the test article extracttreated animals were observedwith clinical signs consistentwith toxicity at any of theobservation periods.	Non-cytotoxic.
ISO Materials Mediated RabbitPyrogen	This response did not exceedthe USP limit and meets therequirements for this test.Therefore, these results indicatethat the test article wasdetermined to be non-pyrogenic.	Non-pyrogenic.
ASTM Hemolysis Assay –Direct Contact and ExtractMethod	There were no significantdifferences between the testarticle extract and negativecontrol article results. The testarticle is considered non-hemolytic.	Non-hemolytic.
Complement activation C3aand SC5b-9 Assay	The levels of C3a and SC5b-9of the test article arecomparable to the comparisonarticle and less than that of thepositive control.	The compliment activation ofthe C3a and SC5b assays weresimilar for test and comparisonarticles.
Thromboresistance Evaluation	The thromboresistanceproperties of the Arc™Catheter are acceptable inclinical use.	The test and control articlesexhibited similarthromboresistantcharacteristics.
ISO Bacterial MutagenicityTest - Ames Assay	Based on the criteria andconditions of the study	Non-mutagenic.
Arc™ Catheter
Test Description	Results	Conclusions
ISO in vitro Mouse Lymphomawith Extended Treatment	protocol, the test article isconsidered non-mutagenic.The test article is considered tobe non-mutagenic (non-genotoxic and non-clastogenic)in this test system.	Non-mutagenic.
ISO in vivo MouseMicronucleus Assay	Based on the criteria of theassay, the test article isconsidered non-mutagenicin this test system.	Non-mutagenic.
Partial Thromboplastin Time	Clotting times for Arc™Catheter were similar to thenegative control and thereference material (HDPE),indicating that the devicematerials are not an activator ofthe intrinsic coagulationpathway.	Non-activator.
in vitro HemocompatibilityAssay	The Arc™ Catheter did notresult in a decrease in anyblood component as comparedto the reference material. Theseresults indicate that the cause ofthrombi is not related to thematerials exposed to humanblood during use	No adverse effect on leukocyteor platelet counts.

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Riptide™ Aspiration Tubing
Test Description	Results	Conclusions
ISO MEM Elution Using L-929Mouse Fibroblast Cells	The test article scored '0' at 24,48 and 72 ± 4 hours and isconsidered non-cytotoxic underthe conditions of this test.	Non-cytotoxic.
ISO Guinea Pig MaximizationSensitization Test	Under the conditions of thisprotocol, the test article did notelicit a sensitization response.	Non-sensitizer.
ISO Intracutaneous IrritationTest	The differences in the mean testand control scores of the extractdermal observations were < 1.0,indicating that the requirementsof the ISO IntracutaneousReactivity Test have been metby the test article.	Non-irritant.
ISO Acute Systemic Injection	None of the test article extract	Non-cytotoxic.

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Riptide™ Aspiration Tubing
Test Description	Results	Conclusions
Test	treated animals were observedwith clinical signs consistentwith toxicity at any of theobservation periods.
ASTM Hemolysis Assay -Extract Method	Based on the criteria set forth inthe protocol, the assay wasvalid. Therefore, it was capableof correctly assessing thehemolytic potential for testarticles. In this case, the testarticle is considered non-hemolytic under the testconditions employed.	Non-hemolytic.
ISO Materials Mediated RabbitPyrogen	This response did not exceedthe USP limit and meets therequirements for this test.Therefore, these results indicatethat the test article wasdetermined to be non-pyrogenic.	Non-pyrogenic.

The Arc™ Catheter and the Riptide™ Aspiration Tubing have been evaluated to meet requirements specified in ISO 10993-1.

Performance Data - Bench:

Non-clinical bench testing was performed for each component of the Riptide™ Aspiration System. Non-clinical bench testing was performed to evaluate the performance of the design modifications incorporated into the Riptide™ Aspiration System.

The following non-clinical bench testing was performed for the Arc™ Catheter:

Arc™ Catheter
Test	Test Method Summary	Results
Microbial
Ethylene Oxide (EO) Residual	EO Residual for the Arc™ Catheter is performed per ISO 10993-7.	The Arc™ Catheter met the acceptance criteria for EO Residual.
Ethylene Chlorohydrin (ECH)	ECH for the Arc™ Catheter is performed per ISO 10993-7.	The Arc™ Catheter met the acceptance criteria for ECH.
Bioburden	Bacterial Endotoxin for the Arc™ Catheter is performed per ANSI/AAMI ST72 and USP 161.	The Arc™ Catheter met the acceptance criteria for Bacterial Endotoxin.
Packaging
Arc™ Catheter
Test	Test Method Summary	Results
Visual Inspection	Visual Inspection for the Arc™ Catheter is performed per ASTM F1886.	The Arc™ Catheter met the acceptance criteria for Visual Inspection.
Bubble Leak	Bubble Leak for the Arc™ Catheter is performed per ASTM F2096.	The Arc™ Catheter met the acceptance criteria for Bubble Leak.
Seal Strength	Seal Strength for the Arc™ Catheter is performed per ASTM F88.	The Arc™ Catheter met the acceptance criteria for Seal Strength.
Performance
Lumen Patency	The proximal hub to the distal tip of the Arc™ Catheter must pass through a stainless-steel mandrel of required size.	The Arc™ Catheter met the acceptance criteria for Lumen Patency.
Dimensional Inspection	The usable length, proximal and distal inner and outer diameter of the Arc™ Catheter is recorded.	The Arc™ Catheter met the acceptance criteria for Dimensional Inspection.
Tip Buckling	The repeated distal tip buckling force under compressive load is evaluated for stiffness.	The Arc™ Catheter met the acceptance criteria for Tip Buckling.
Injection Flow Rate	Injection Flow Rate for the Arc™ Catheter is performed per ISO 10555-1, Annex E with injection through the proximal hub.	The Arc™ Catheter met the acceptance criteria for Injection Flow Rate.
Suction Flow Rate	Suction Flow Rate for the Arc™ Catheter is performed per ISO 10555-1, Annex E with injection through the distal tip.	The Arc™ Catheter met the acceptance criteria for Suction Flow Rate.
Vacuum Resistance	Vacuum Resistance for the Arc™ Catheter is performed under static conditions using a 60cc syringe.	The Arc™ Catheter met the acceptance criteria for Vacuum Resistance.
Air Aspiration Leak	Air Aspiration Leak for the Arc™ Catheter is performed per ISO 10555-1, Annex D.	The Arc™ Catheter met the acceptance criteria for Air Aspiration Leak.
Hub/Shaft Peak Tensile Force	Hub/Shaft Peak Tensile Force for the Arc™ Catheter is performed per ISO 10555-1, Annex B.	The Arc™ Catheter met the acceptance criteria for Hub/Shaft Peak Tensile Force.
Coating Integrity	Coating Integrity for the Arc™ Catheter was assessed using a staining method pre and post.	Characterization only.
ArcTM Catheter
Test	Test Method Summary	Results
Coating Lubricity/Durability	simulation to estimated coatingcoverage.	The ArcTM Catheter met theacceptance criteria for CoatingLubricity/Durability.
Particulate	Particulate for the ArcTMCatheter was performed in atortuous model per USP <788>.	ArcTM Catheter met theacceptance criteria forParticulate.
Kink Resistance	Kink Resistance for the ArcTMCatheter is performed with thedevice wrapped around a rod orknown radius at which pointthe ArcTM Catheter is inspectedfor kinking.	The ArcTM Catheter met theacceptance criteria for KinkResistance.
Liquid Leak	Liquid Leak for the ArcTMCatheter is performed per ISO10555-1, Annex C.	The ArcTM Catheter met theacceptance criteria for LiquidLeak.
Static/Dynamic Burst	Static/Dynamic Burst for theArcTM Catheter is performedper ISO 10555-1, Annex F.	The ArcTM Catheter met theacceptance criteria forStatic/Dynamic Burst.
Corrosion Resistance	Corrosion Resistance for theArcTM Catheter is performedper ISO 10555-1, Annex A.	The ArcTM Catheter met theacceptance criteria forCorrosion Resistance.
Torque to Failure	The ArcTM Catheter isnavigated through a tortuousmodel where the distal tip issecured, and the proximal endof the catheter is rotated 360°.The total number of 360°rotations prior to failure isrecorded	Characterization only.

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The following non-clinical bench testing was performed for the Riptide™ Aspiration Tubing:

Riptide™ Aspiration Tubing
Test	Test Method Summary	Results
Microbial
Ethylene Oxide (EO) Residual	EO Residual for the Riptide™ Aspiration Tubing is performed per ISO 10993-7.	The Riptide™ Aspiration Tubing met the acceptance criteria for EO Residual.
Ethylene Chlorohydrin (ECH)	ECH for the Riptide™ Aspiration Tubing is performed per ISO 10993-7.	The Riptide™ Aspiration Tubing met the acceptance criteria for ECH.
Riptide™ Aspiration Tubing
Test	Test Method Summary	Results
Bioburden Recovery	Bioburden Recovery for theRiptide™ Aspiration Tubing isperformed perANSI/AAMI/ISO 11737-1.	The Riptide™ AspirationTubing met the acceptancecriteria for BioburdenRecovery.
Bioburden	Bioburden for the Riptide™Aspiration Tubing is performedper ANSI/AAMI/ISO 11737-1.	The Riptide™ AspirationTubing met the acceptancecriteria for Bioburden.
Bacterial Endotoxin	Bacterial Endotoxin for theRiptide™ Aspiration Tubing isperformed per ANSI/AAMIST72.	The Riptide™ AspirationTubing met the acceptancecriteria for Bacterial Endotoxin.
Packaging
Aseptic Presentation	Aseptic Presentation for theRiptide™ Aspiration Tubing isperformed for delamination.	The Riptide™ AspirationTubing met the acceptancecriteria for AsepticPresentation.
Seal Width	Seal Width for the Riptide™Aspiration Tubing is performedper ASTM F2203.	The Riptide™ AspirationTubing met the acceptancecriteria for Seal Width.
Dye Leak	Dye Leak for the Riptide™Aspiration Tubing is performedper ASTM F1929.	The Riptide™ AspirationTubing met the acceptancecriteria for Dye Leak.
Visual Inspection	Visual Inspection for theRiptide™ Aspiration Tubing isperformed per ASTM F1886.	The Riptide™ AspirationTubing met the acceptancecriteria for Visual Inspection.
Bubble Leak	Bubble Leak for the Riptide™Aspiration Tubing is performedper ASTM F2096.	The Riptide™ AspirationTubing met the acceptancecriteria for Bubble Leak.
Legibility	Legibility for the Riptide™Aspiration Tubing is performedfor smearing or degradation.	The Riptide™ AspirationTubing met the acceptancecriteria for Legibility.
Foreign Material	Foreign Material on theRiptide™ Aspiration Tubing isperformed via visualinspection.	The Riptide™ AspirationTubing met the acceptancecriteria for Foreign Material.
Seal Strength	Seal Strength for the Riptide™Aspiration Tubing is performedper ASTM F88.	The Riptide™ AspirationTubing met the acceptancecriteria for Seal Strength.
Performance
Dimensional Inspection	The overall and distal length,proximal and distal inner andouter diameter of the Riptide™Aspiration Tubing is recorded.	The Riptide™ AspirationTubing met the acceptancecriteria for DimensionalInspection
Riptide™ Aspiration Tubing
Test	Test Method Summary	Results
Identification of Heat ShrinkBands	The heat shrink bands of theRiptide™ Aspiration Tubingare visually inspected.	The Riptide™ AspirationTubing met the acceptancecriteria for Identification of theHeat Shrink Bands.
Identification of Flow Switch	The flow switch of theRiptide™ Aspiration Tubing isvisually inspected.	The Riptide™ AspirationTubing met the acceptancecriteria for Identification of theFlow Switch.
Joint Tensile Strength	The Riptide™ AspirationTubing is affixed to upper andlower grips of the tensile testfixture and stretched. Themaximum value before failureis recorded.	The Riptide™ AspirationTubing met the acceptancecriteria for Joint TensileStrength.
Leak	The Riptide™ AspirationTubing is pressurized tospecified vacuum pressure andany decay in pressure isrecorded	The Riptide™ AspirationTubing met the acceptancecriteria for Leak (Vacuum andPressure Decay).
Degree of Collapse	Degree of Collapse for theRiptide™ Aspiration Tubing isperformed per ISO 10079-3.	The Riptide™ AspirationTubing met the acceptancecriteria for Degree of Collapse.
Compatibility	The distal end of the Riptide™Aspiration Tubing is connectedto the proximal hub of theArc™ Catheter. The proximalend of the Riptide™ AspirationTubing is connected to thehorizontal port of the Riptide™Collection Canister	The Riptide™ AspirationTubing met the acceptancecriteria for Compatibility to theArc™ Catheter and Riptide™Collection Canister.

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The following non-clinical bench testing was performed for the Riptide™ Aspiration Pump:

Riptide™ Aspiration Pump
Test	Test Method Summary	Results
Degrees of Tilt	The test axes of the Riptide™Aspiration Pump are pivoted45° and does not tip over.	The Riptide™ Aspiration Pumpmet the acceptance criteria forDegrees of Tilt.
Durability	The Riptide™ Aspiration Pumpis functional through 500 hoursof expected service life.	The Riptide™ Aspiration Pumpmet the acceptance criteria forDurability.
Maximum Vacuum	The vacuum control valve ofthe Riptide™ Aspiration Pumpis set to maximum vacuum and	The Riptide™ Aspiration Pumpmet the acceptance criteria forMaximum Vacuum.

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Riptide™ Aspiration Pump
Test	Test Method Summary	Results
	recorded.
Flow Capacity	The Riptide™ Aspiration Pumpwas ran at specified pressureprior to recording the air flow.	The Riptide™ Aspiration Pumpmet the acceptance criteria forFlow Capacity.
Electrical Safety	Electrical safety for theRiptide™ Aspiration Pump isperformed per IEC 60601-1.	The Riptide™ Aspiration Pumpmet the acceptance criteria forElectrical Safety
Electromagnetic Compatibility	Electromagnetic compatibilityfor the Riptide™ AspirationPump is performed per IEC60601-1-2.	The Riptide™ Aspiration Pumpmet the acceptance criteria forElectromagnetic Compatibility.

The following non-clinical bench testing was performed for the Riptide™ Canister with Intermediate Tubing:

Riptide™ Collection Canister with Intermediate Tubing
Test	Test Method Summary	Results
Packaging
Packaging Integrity	Packaging Integrity for theRiptide™ Collection Canisterwith Intermediate Tubing isperformed per ISTA 2A andATSM D4169.	The Riptide™ CollectionCanister met the acceptancecriteria for Packaging Integrity.
Packaging Labeling	Packaging Labeling for theRiptide™ Collection Canisterwith Intermediate Tubing isperformed to ensure thelabeling remains affixed andlegible over the labeled shelflife of three (3) months.	The Riptide™ CollectionCanister met the acceptancecriteria for Packaging Labeling.
Performance
Volume Capacity	The Riptide™ CollectionCanister is visually inspected toensure graduations up to1200mL.	The Riptide™ CollectionCanister met the acceptancecriteria for Volume Capacity.
Volume Marking	The Riptide™ CollectionCanister is visually inspected toensure graduations in 100mL.	The Riptide™ CollectionCanister met the acceptancecriteria for Volume Marking.
Canister Strength	The Riptide™ CollectionCanister is tested for canisterstrength per ISO 10079-3.	The Riptide™ CollectionCanister met the acceptancecriteria for Canister Strength.
Overfill Protection	The Riptide™ CollectionCanister is tested for overfill	The Riptide™ CollectionCanister met the acceptance

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Riptide™ Collection Canister with Intermediate Tubing
Test	Test Method Summary	Results
Dimensional Inspection	protection per ISO 10079-3.The overall length of theIntermediate Tubing isrecorded.	criteria for Overfill Protection.The Intermediate Tubing metthe acceptance criteria forDimensional Inspection.
Degree of Collapse	Degree of Collapse for theIntermediate Tubing isperformed per ISO 10079-3.	The Intermediate Tubing metthe acceptance criteria forDegree of Collapse.
Port Identification	The Riptide™ CollectionCanister is visually inspected toensure the connection ports arecorrectly labeled.	The Riptide™ CollectionCanister met the acceptancecriteria for Port Identification.
Compatibility	The Intermediate Tubing isconnected to the vacuum inletport of the Riptide™ AspirationPump.	The Intermediate Tubing metthe acceptance criteria forCompatibility.

The following non-clinical bench testing was performed for the Riptide™ Aspiration System:

Riptide™ Aspiration System
Test	Test Method Summary	Results
Simulated Clot Retrieval	The Arc™ Catheter is navigated through a tortuous model to the intended treatment location for simulated clot retrieval.	The Riptide™ Aspiration System met the acceptance criteria for Simulated Clot Retrieval.
Vacuum Pressure	The vacuum pressure experienced at the distal tip of the Arc™ Catheter is recorded.	The Riptide™ Aspiration System met the acceptance criteria for Vacuum Pressure.
Flow Rate	The flow rate through the Arc™ Catheter is recorded under full-flow conditions.	The Riptide™ Aspiration System met the acceptance criteria for Flow Rate.
Lumen Collapse	The Arc™ Catheter is navigated through a tortuous model and subjected to maximum vacuum pressure generated by the Riptide™ Aspiration Pump at which point the catheter is inspected for any collapse or damage.	The Arc™ Catheter is resistant to Lumen Collapse.
Usability	The Penumbra System® and Penumbra Pump MAX™ and the Riptide™ Aspiration System were evaluated for navigability, flexibility, the	The Riptide™ Aspiration System met the acceptance criteria for Usability.

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Riptide™ Aspiration System
Test	Test Method Summary	Results
	ability to engage and applyaspiration, and for the ability tosafely retrieve clot by endusers.

The non-clinical bench testing, as described above, indicates that the Riptide™ Aspiration System is substantially equivalent to the Penumbra System® and Penumbra Pump MAXTM.

Performance Data - Animal:

Non-clinical animal testing was performed to evaluate the safety, efficacy, and usability of the Riptide™ Aspiration System in comparison to the Penumbra System® and Penumbra Pump MAX™ at acute and chronic time points in a porcine model, both in the presence and absence of simulated clot. Non-clinical animal testing was performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.

The non-clinical animal testing, as described above, indicates that the Riptide™ Aspiration System is substantially equivalent to the Penumbra System® and Penumbra Pump MAXTM.

Performance Data - Clinical:

Not Applicable. A determination of substantial equivalence is based upon non-clinical bench and animal testing.

Conclusion:

The design modifications incorporated into the Riptide™ Aspiration System do not alter the fundamental scientific technology or intended use.

Non-clinical bench and animal testing supports a determination that the subject RiptideTM Aspiration System is substantially equivalent to the predicate Penumbra System® and Penumbra Pump MAX™.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).